CDA | Evidence Driven
CDA | Evidence Driven

pembrolizumab

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Generic Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
Esophageal carcinoma, gastroesophageal junction adenocarcinoma
Manufacturer:
Merck Canada
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0250-000
Tumour Type:
Head and Neck
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
First-line treatment of locally advanced unresectable or metastatic, carcinoma of the esophagus or HER-2 negative gastroesophageal junction adenocarcinoma in combination with platinum and fluoropyrimidine based chemotherapy, in adult patients.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
First-line treatment of locally advanced unresectable or metastatic, carcinoma of the esophagus or HER-2 negative gastroesophageal junction adenocarcinoma in combination with platinum and fluoropyrimidine based chemotherapy, in adult patients.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open14-Apr-21
Call for patient/clinician input closed04-Jun-21
Clarification:

- Patient input submission received from Colorectal Cancer Canada, Gastrointestinal Society, and My Gut Feeling - Stomach Cancer Foundation of Canada.

Submission received26-May-21
Submission accepted09-Jun-21
Review initiated10-Jun-21
Draft CADTH review report(s) provided to sponsor for comment25-Aug-21
Deadline for sponsors comments03-Sep-21
CADTH responses on draft review report(s) provided to sponsor29-Sep-21
Expert committee meeting (initial)13-Oct-21
Draft recommendation issued to sponsor27-Oct-21
Draft recommendation posted for stakeholder feedback04-Nov-21
End of feedback period18-Nov-21
Final recommendation issued to sponsor and drug plans02-Dec-21
Final recommendation posted20-Dec-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)16-Dec-21
CADTH review report(s) posted04-Feb-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submissions View PDF
Clinician Input View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : December 23, 2021